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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04820816
Other study ID # 012-003133
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 15, 2021

Study information

Verified date March 2021
Source MTI University
Contact Noha Abbas, Bachelor
Phone 00201060742720
Email Noha.Abbas@pt.mti.edu.eg
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

There is a debate in the literature about the effect of NSLBP on pelvic tilt and its effect on balance, sensory integration and functional disability so we need this study to fill the aforementioned gap in literature in this field. So the purpose of the study is to evaluate posterior pelvic tilt effect on overall dynamic balance, sensory integration and functional disability in patients with non-specific low back pain.


Description:

The LBP became one of the biggest problems for public health systems in the world during the second half of the 20th century. The lifetime prevalence of LBP is reported to be as high as 84%, and the prevalence of chronic LBP is about 23%, with 11-12% of the population being disabled by LBP. Prevalence of LBP was 53.2%. It was more among female patients (62.8%) than among male patients (38.3%) among attendants to a Family Health Center in Egypt. Additionally, studies have observed relationships between chronic non-specific LBP and a posteriorly shifted center of gravity, impaired proprioception, and decreased muscular strength, activation and endurance of the trunk and hips. Balance is impaired in individuals with chronic low back pain when compared to healthy individuals. Most of these studies supposed that postural mal-alignment involves deviations in only one direction which is toward lordosis and anterior pelvic tilt. However, clinical experience suggests that some patients with back pain have the opposite problem which is a much reduced lordotic curve and a posterior pelvic tilt. If the true relationship between posture and low back pain disability is curvilinear instead, this could explain why the studies so far have shown weak or no relationships.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 15, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: 1. Fifty patients with chronic low back pain or repeated non-specific back pain for more than three months. 2. Both sex with posterior pelvic tilt (-0.7 ± 6.5°)and decreased lumbar lordosis, for (Group A) and normal anterior pelvic tilt angle between 5° and 13° for (Group B) 3. Their ages were ranged from 20-35 years. 4. Body Mass Index from 18-25 Kg/m² . Exclusion Criteria: 1. Previous back surgery. 2. Signs and symptoms of gross spinal instability. 3. Radiological diagnosis of spondylolysis or spondylolisthesis. 4. Acute low back pain. 5. Disc prolapse or herniation. 6. Any neurological, orthopedic, and vestibular disorders affecting the balance system. 7. Flexion and extension restriction of the lumbar region. 8. Other conditions that affected the normal functioning of the central and peripheral nervous system such as alcohol abuse, addiction, dementia, and cognitive disorders.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pelvic tilt effect on balance, sensory integration and risk of fall
BIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test

Locations

Country Name City State
Egypt Noha Abbas Abdelaziz Ali Cairo

Sponsors (1)

Lead Sponsor Collaborator
MTI University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biodex balance system Limits of stability test A test measures dynamic postural stability in percentage 10 minuets
Primary Biodex balance system m-CTSIB test A test measures postural sway control to assess sensory integration. 10 minuets
Primary Biodex balance system Fall risk test (FR) A test to assess risk of fall according to mean age 10 minuets
Primary Oswestry Disability Index (ODI) An index to assess physical functioning in percentage. 10 minuets
Secondary The Global Posture System (GPS) 600 A device to assess degree of pelvic tilt angle in degrees. 10 minuets
Secondary Body Mass Index (weight in kilograms, height in meters) kg/m^2 10 minuets
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